• J D Hainsworth and F A Greco.
• Sarah Cannon Cancer Center, Nashville, TN 37203, USA.
• Semin. Oncol. 1995 Dec 1; 22 (6 Suppl 15): 45-9.

AbstractPaclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given as a 1-hour infusion potentially offers its recipients reduced toxicity, demonstrated efficacy, and greater ease of administration. To confirm this hypothesis, we undertook a phase I/II study of 1-hour, single-agent paclitaxel in 164 patients' refractory malignancies; 59 patients with recurrent or stage IV non-small cell lung cancer (NSCLC) participated in the study. Our objective was to compare two paclitaxel doses (135 and 200 mg/m2) and two 1-hour infusion schedules (1 hour in 1 day, or 1 hour each day for 3 days, divided dose). Results from this study show that paclitaxel given over 1 hour possesses marked antitumor activity. In patients with NSCLC, the overall response rate was 25%, with a higher response rate among higher-dose recipients (31% v 12%). These promising results with single-agent paclitaxel prompted phase II trials of combination therapy incorporating the 1-hour paclitaxel infusion. Twenty-three patients with locally advanced, unresectable stage IIIA or IIIB NSCLC have been treated with 1-hour paclitaxel and cisplatin/etoposide plus radiation therapy. Three patients have had complete responses (CRs) and another five have had "near CRs," defined as only nonspecific abnormalities in previously irradiated areas on computed tomography. Five patients had partial responses. Although the median follow-up is only 9 months, it is encouraging that disease has recurred in only one of the eight patients with CR or near CR and that toxicity has been manageable. Another phase II trial is evaluating 1-hour paclitaxel, carboplatin, and extended-schedule etoposide in patients with limited or extensive small cell lung cancer. Of the 22 patients now evaluable for response (median follow-up, 8 months), 10 (six with limited and four with extensive small cell lung cancer) have achieved CRs and 11 have achieved partial remissions. The regimen is well tolerated. The final results of these and other phase II trials should help clarify optimal paclitaxel schedules and regimens for large-scale randomized trials in patients with lung cancer.

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